Astellas was hit with another gene therapy clinical hold, but the Japanese pharma signed two partnerships focused on novel antibody-drug conjugate technology and undruggable targets. Fujifilm is pouring $1.6 billion to bolster its cell culture manufacturing services at its CDMO facilities in Denmark and Texas. And more.
1. Astellas' gene therapy strategy faces fresh setback as FDA puts Pompe disease med on hold
Astellas just can’t catch a break with its gene therapy headache. The FDA has put yet another clinical hold on one of the Japanese pharma’s gene therapies it bought along with Audentes Therapeutics. The phase 1/2 Pompe disease trial is now frozen after one patient developed peripheral sensory neuropathy. The latest hold followed several others for an Astellas gene therapy for the rare disease X-linked myotubular myopathy.
2. Fujifilm plots $1.6B expansion at CDMO sites in Denmark and Texas, adding 450 jobs
Fujifilm unveiled a $1.6 billion investment in the cell culture manufacturing services at its CDMO sites in Hillerød, Denmark, and Texas. In Denmark, the company is adding eight 20,000-liter bioreactors, bring the total count to 20. It will also add two downstream processing streams. Investment at the Texas site will expand cell culture manufacturing capabilities and enable continuous processing.
3. Astellas pays Sutro $90M to hit cancer with one-two punch from new ADC modality
Astellas is paying Sutro Biopharma $90 million upfront for rights to three immunostimulatory antibody-drug conjugates. Sutro’s technology allows researchers to conjugate a cytotoxic and immune-boosting payload on an antibody. Astellas will be on the hook for more than $1 billion if the three programs hit their milestones.
In another deal, Astellas’ Mitobridge subsidiary has partnered with Generian on the discovery of small molecules against undruggable targets. The deal includes an undisclosed upfront payment, plus up to $180 million tied to milestones. Bought by Astellas in 2017, Mitobridge focuses on drugs that target mitochondrial function.
Lundbeck and Otsuka said Rexulti beat placebo at reducing agitation in patients with Alzheimer’s disease dementia after 12 weeks in a phase 3 trial. While detailed results aren’t yet available, the pair said it plans to file with the FDA later this year.
6. Amgen partners with Fosun to bring Otezla, Parsabiv to patients in China
Amgen has found another partner in China. The Big Biotech has tapped Fosun Pharma to help sell psoriasis drug Otezla and hyperparathyroidism therapy Parsabiv in the country. Back in 2019, Amgen teamed with BeiGene to run point with Xgeva, Kyprolis and Blincyto in China as well as certain pipeline programs.
7. BeiGene, Novartis target Merck, BMS territory with PD-1 esophageal cancer survival win (release)
Following a disease progression win, BeiGene and partner Novartis rolled out new data showing their PD-1 inhibitor tislelizumab, used on top of chemo, could cut the risk of death by 34% over chemo alone in newly diagnosed advanced esophageal squamous cell carcinoma regardless of PD-L1 expression. Merck’s Keytruda and Bristol Myers Squibb’s Opdivo have both been approved in this indication.
8. WuXi debuts another high-potency API production facility in China
WuXi STA has opened a high-potency active pharmaceutical ingredient production facility at its Changzhou site in China. The facility has reactors ranging from 250 liters to 3,000 liters. The plant can handle linkers, oligonucleotides and peptides for complex conjugate modalities.
9. Clover's COVID booster bolsters antibody levels against omicron
China’s Clover Biopharmaceuticals said a booster shot of its COVID vaccine, SCB-2019, elevated neutralizing antibody levels 19-fold against the omicron BA.2 variant and 12-fold against the omicron BA.1 variant. The company aims to complete first filings in China and Europe as well as with the World Health Organization this year.
10. Fujifilm picks up AI program for guiding IVF procedures
Fujifilm has bought an artificial intelligence program for in vitro fertilization from Brigham and Women’s Hospital and Massachusetts General Hospital. The software analyzes pictures of human embryos to help find the healthiest candidates for implantation. Fujifilm plans to offer nonexclusive licenses to other fertility facilities.